1、Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been gi
2、ven support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, w
3、ater, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution,
4、 “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than
5、2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing t
6、imber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “
7、bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral
8、resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary Riv
9、er Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of
10、three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivost
11、ok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Orienta
12、l Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi药事法规考试讲义一、填空题：1、开办药品经营企业，必须具有依法经过资格认定的 药学技术人员 。2、药品通用名称字体颜色应当使用 黑色 或者白色。3、药品经营企业不得经营麻醉药品原料药和 第一类精神药品 原料药。4、药品不良反应是指 合格 药品在正常用法用量下出现的与用药目的无关的或意外的有害反应。5、 药品召回管理办法规定：药品经营企业发现其经营的药品存在安全隐患 的，应 当 立 即 停 止 销 售 和 使 用 该
13、 药 品。6、进口药品必须取得国家食品药品监督管理局核发的 进口药品注册证 或医药产品注册证 。7、按照批签发管理的生物制品在销售时，必须提供加盖本企业印章的生物制品 批签发 合格证复印件。8、药品广告的内容必须 真实、合法 ，不得含有虚假的内容。9、国 家 基 本 药 物 的 遴 选 原 则 为 ： 临 床 必 需 、 安 全 有 效 ， 价 格 合 理 、 使 用 方 便 、 中 西 药并 重 。10、 药 品 销 售 者 应 当 按 照 药 品 管 理 法 以 及 特 别 规 定 第 五 条 的 规 定 建 立 并 执 行 进 货 检 查 验收 制 度 ， 购 销 记 录 保 存 期 限
14、 不 得 少 于 2 年 。11、药品经营范围，是指经药品监督管理部门核准经营药品的品种类别。12、药品生产、经营企业不得在经药品监督管理部门核准的地址以外的场所储存或者现货销售药品。13、执 业 药 师 是 指 经 全 国 统 一 考 试 合 格 ， 取 得 执 业 药 师 资 格 证 书 并 经 注 册 登 记 ， 在 药 品 生 产 、经 营 、 使 用 单 位 中 执 业 的 药 学 技 术 人 员 。14、 药 品 商 品 名 称 不 得 与 通 用 名 称 同 行 书 写 ， 其 字 体 以 单 字 面 积 计 不 得 大 于 通 用 名 称 所 用 字 体 的 二分 之 一 。1
15、5、 非 处 方 药 专 有 标 识 图 案 分 为 红 色 和 绿 色 ， 红 色 专 有 标 识 用 于 甲 类 非 处 方 药 药 品 。16、国家对麻醉药品和精神药品实行定点经营制度。17、药品经营企业 GSP 认证跟踪检查发现存在 3 条以上严重缺陷项目的企业，检查组应现场收回该企业药品经营质量管理规范认证证书 ，并上缴发证机关。Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural
16、and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all
17、the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kil
18、ometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“
19、 Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing
20、 grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more speci
21、es precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billi
22、on cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along t
23、he border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary River Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities
24、 (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail
25、 and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivostok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in touris
26、m resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Oriental Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi218、药品批发和零售连锁企业应根据所经营药品的储存要求，设置不同温度、湿度
27、条件的仓库。其中常温库温度为 0-30。19、非药品不得在其包装、标签、说明书及有关宣传资料上进行含有预防、治疗、诊断人体疾病等有关内容的宣传。20、药品广告必须标明药品生产企业或药品企业名称，不得单独出现咨询热线、咨询电话等内容。二、名词解释1、首营企业：购进药品时，与本企业首次发生供需关系的药品生产或经营企业。2、首营品种：本企业向某一药品生产企业首次购进的药品。3、处方药：必须凭执业医师或执业助理医师处方方可调配、购买和使用的药品。4、非处方药：国务院药品监督管理部门公布的，不需要凭执业医师或执业助理医师处方即可自行判断、购买和使用的药品。三、简答题1、生产、销售假药应承担的法律责任。生
28、产、销售假药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额二倍以上五倍以下罚款；有药品批准证明文件的予以撤销，并责令停产、停业整顿；情节严重的，吊销药品生产许可证 、 药品经营许可证或者医疗机构执业许可证 ；构成犯罪的，依法追究刑事责任。2、药品出库应遵循什么原则？药品出库应遵循“先产先出” 、 “近期先出”和按批号发货的原则。3、生产、销售劣应承担的法律责任。生产、销售劣药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额一倍以上三倍以下罚款；情节严重的，责令停产、停业整顿或者撤销药品批准证明文件、吊销药品生产许可证 、 药品经营许可证或者医疗机构
29、执业许可证 ；构成犯罪的，依法追究刑事责任。4、在哪些情形下， 药品经营许可证由原发证机关予以注销？药品经营许可证有效期届满未换证的；Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Governm
30、ent, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). O
31、ne is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at
32、the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (whi
33、ch owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, ri
34、ch in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mounta
35、in dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, Nor
36、th cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight transport port, built on the bor
37、der between China and Russia has the largest permanent boundary River Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX por
38、t corresponding to the port of markovo, Lu Rinuo station is one of three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eas
39、tern European countries; to the South through the port of Vladivostok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-
40、river-wusuli River, a famous treasure island, known as the “Oriental Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi3药品经营企业终止经营药品或者关闭的；药品经营许可证被依法撤销、撤回、吊销、收回、缴销或者宣布无效的；不可抗力导致药品经营许可证的许可事项无法实施的；法律、法规规定的应当注销行政许可的其他情形。四、案例分析题1、近日，某药监局接群众投诉举报，称某药品经营企业无证批发药品。执法人员经检
41、查销售奨据发现，该药品经营企业药品经营许可证核准的经营方式为零售，但将药品出 给药品零售经营企业，销售药品货 金额 1元，执法人员遂沁收了其违法销售的药品和违法所得，并处 0 万元璄罚款。请析该企经营行为违反了药品流通监督管理办法哪一条规定？具体内容昧什么？对该企业进行的行政处罚是否正确？说明理由。獔：该企业经营行为违反了药品流通监管办法第十七条规定：未经药品监督管理胨门审核同意，药品经营 业不得改变经营方式。药品经营企业应当按照 药品经营许可证 许可的经营范围经营药品。本案中，药品经营许可证核准的经营方式为零售，未批准其进行批发，却将药品出售给药品零售经营企业，构成违法批发药品。没收其违法销
42、售的药品和违法所得正确，但处以 1 万元罚款不正确。该企业违法经营行为应依照药品管理法第七十三条规定，没收违法销售的药品和违法所得，并处违法销售的药品货值金额二倍以上五倍以下的罚款。本案中，应罚款 2 万至 5 万元。2、甲县食品药品监管局执法人员在对该县乙零售药店进行 GSP 跟踪检查时发现，乙药店经营的“注射用头孢哌酮钠”贮藏条件标示为“密闭，冷处贮藏”，而该药店的“注射用头孢哌酮钠”却在常温环境下陈列销售，药店无冷藏设施，温、湿度计显示室内温度为 25。检查乙药店各项记录显示，该药店共计购入注射用头孢哌酮钠 200 支，货值 1600 元，销售出 50 支，销售收入 400 元，全部凭处
43、方销售，库存 150 支。乙药店负责人在调查笔录中也承认，药店无冷藏设施，购入注射用头孢哌酮钠后未进行冷藏贮存。请分析：该企业违反了药品经营质量管理规范哪两条规定？具体内容是什么？Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal part
44、y Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality locat
45、ed (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution s
46、ources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million
47、 mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million a
48、cres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super
49、 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopolitical advantag
